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Reducing antibiotic use for uncomplicated urinary tract infection in general practice by treatment with bearberry leaf extract

Phase 1
Conditions
uncomplicated urinary tract infection
MedDRA version: 20.0Level: LLTClassification code 10046544Term: Urinary infectionSystem Organ Class: 100000004862
Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
Registration Number
EUCTR2016-000477-21-DE
Lead Sponsor
Georg-August-Universität Göttingen, Stiftung Öffentlichen Rechts, Universitätsmedizin Göttingen
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
Female
Target Recruitment
430
Inclusion Criteria

- Women (18-75 years) with suspected UTI

- at least two Symptoms of UTI (dysuria, urgency of micturition, frequency, lower abdominal pain)

- Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

- signs of complicated UTI (e. g. temperature > 38°C, loin tenderness)

- conditions that may lead to complicated infections (i.e. renal diseases, patients with urinary catheter)

- pregnancy/ breastfeeding

- current self-medication with UU preparations

- antibiotic use in the last 7 days

- previous UTI in the past 2 weeks

- history of pyelonephritis

- contraindications for trial drugs

- serious diseases

- inability to understand trial Information

- current participation in another clinical trial or participation in another clinical trial within the last 4 weeks

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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